Foods

By Riëtte van Laack –
Yesterday, FDA announced the availability of a webpage providing information to industry regarding the requirements of the recently finalized Nutrition Facts and serving size regulations.
FDA clarifies that until the compliance date of July 26, 2018 (or July 26, 2019 for companies …

By Ricardo Carvajal –
In an unusual “Early Alert,” the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) publicly took FDA to task for allegedly lacking “an efficient and effective food recall initiation process that helps ensure the safety of …

By Riëtte van Laack
As we reported previously, in 2013, Health Science Funding, LLC (HSF) filed what might be the first medical food lawsuit against FDA. Plaintiff markets a medical food for women with lupus, Prastera® DHEA. Medical foods may be marketed without pre-market approval by …

By Jenifer R. Stach & Ricardo Carvajal –
Carrying through on what had been designated as a high priority item, FDA rolled out its sodium reduction initiative with several actions, all on the same day. On June 1, 2016, FDA published a Federal Register notice to announce …

By Riëtte van Laack –
On May 27, 2016, FDA published the final rule, required under FSMA, regarding “the Mitigation Strategies to Protect Food against Intentional Adulteration.”
Food defense has been on the agenda ever since the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 …

By Riëtte van Laack –
On Friday the 20th of May, FDA announced the availability of the final regulations for nutrition labeling and serving sizes (in prepublication format). The final regulations will be published in the Federal Register on May 27, 2016. That date will be used …

By Riëtte van Laack –
FDA announced the availability of the Final Guidance for Medical Foods: “Frequently Asked Questions About Medical Foods; Second Edition.”
As we previously reported, in August 2013, FDA issued a draft guidance, updating the 2007 guidance for medical foods. In the 2013 draft …

By Etan J. Yeshua –
Today, FDA officially announced the availability of a final guidance document that answers questions about the Agency’s menu labeling rule. In doing so, FDA also set May 5, 2017 as the rule’s enforcement date. Although there are only a few differences …

By Riëtte van Laack & Wes Siegner –
Under the FDC Act, dog and cat food products that are intended to treat or prevent disease and to provide nutrients in support of the animal’s daily nutrient needs can be regulated as drugs or foods or both. …

By Riëtte van Laack –
Last year (October 2015), POM Wonderful LLC (POM) petitioned the U.S. Supreme Court for review of the decision of the U.S. Court of Appeals for the District of Columbia (see our previous post here). As we discussed, POM’s arguments in its …

By Riëtte van Laack –
As we have reported on several occasions, “natural claims,” particularly when used in the advertising of food and dietary supplements, are frequently challenged by competitors and consumers. Neither the Federal Food, Drug, and Cosmetic Act (FDC Act), nor FDA regulations, nor …

By Riëtte van Laack –
Last week, FDA issued the sixth of the seven major rules expected to issue under the authority of the Food Safety Modernization Act (FSMA), namely the final rule for Sanitary Transportation of Human and Animal Food. Although FSMA directed FDA to …

By Jay W. Cormier –
Just a little more than four months after FDA approved AquAdvantage Salmon (AAS) – the first genetically engineered (GE) animal intended for food use – several organizations filed suit against FDA and the U.S. Fish and Wildlife Service (FWS) challenging that approval. Plaintiffs …

By Ricardo Carvajal –
That’s our take-away from FDA’s recent public meeting on the implementation of FSMA’s import provisions and the associated regulations (FSVP, VQIP, and Accredited Third Party Certification). Several comments made at the meeting suggest that many importers may still be unaware of the advent …